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510(k) K914358

ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP by Hobbs Medical, Inc. — Product Code EYB

K914358 is an FDA 510(k) premarket notification submitted by Hobbs Medical, Inc. for the device "ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP". The FDA issued a decision of Substantially Equivalent on November 19, 1991. The device falls under product code EYB (Catheter, Ureteral, Gastro-Urology), a Class II device regulated under 21 CFR 876.5130. Hobbs Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1991
Date Received
October 1, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ureteral, Gastro-Urology
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Hobbs Medical, Inc.

  • K241874 — Aspiration Catheter (2189) (September 24, 2024)
  • K182927 — Pulmonary Cytology Brush (February 7, 2020)
  • K093079 — TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, (August 2, 2010)
  • K030765 — HOBBS MISTIFIER SPRAY CATHETER (June 9, 2003)
  • K933354 — HOBBS MEDICAL CLEANING BRUSH (October 28, 1993)
  • K922396 — FUJINON FORCEPS -- MODIFICATION (December 10, 1992)
  • K921026 — PRESSURE GAUGE (April 24, 1992)
  • K893729 — HOBBS MEDICAL MICROBIOLOGY BRUSH (August 28, 1989)
  • K872509 — LINDEN STONE EXTRACTION BALLOON (September 22, 1987)
  • K860593 — ET/RT PAPILLOTOME (July 22, 1986)

Other clearances for product code EYB

  • K192183 — RocaTub Ureteral Catheter (April 23, 2020)
  • K191187 — Dornier MINNOW Ureteral Catheter (September 18, 2019)
  • K183323 — UPJ Occlusion Balloon Catheter (August 5, 2019)
  • K182695 — Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter (June 17, 2019)
  • K182122 — Ureteric Catheters (October 4, 2018)
  • K180182 — Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Cathet (September 14, 2018)
  • K171043 — Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric C (December 21, 2017)
  • K133750 — OCCLUDER OCCLUSION BALLOON CATHETER (January 8, 2014)
  • K092250 — MEDLINE RED RUBBER URETHRAL CATHETER (January 21, 2010)
  • K083788 — ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR (March 3, 2009)

FDA data resources